Pre-Approval Commercialization

Find presenter-approved materials from the Pre-Approval Commercialization ASGCT Pre-Meeting Workshop

The Pre-Approval Commercialization Workshop covers industry perspectives on CMC Challenges for cell and gene modified cell therapy products, updates from global regulatory bodies, manufacturing challenges in late phase development of gene therapy products, and discussions on the difficulties in commercializing AAV product candidates.

2019 Workshop Materials

Misalignment of Academia and Industry Impedes Clinical Gene Therapy for Rare Diseases

Harrison Brown, Ph.D.—Odylia Therapeutics

FDA’s Approach to Facilitating the Development of Gene Therapies

Peter Marks, M.D., Ph.D.—FDA CBER

CMC challenges in autologous CAR T products

Toko Momonoi, M.S.—Celgene Corporation

Marketing Authorisations of Advanced Therapies in EU– a regulatory update by the EMA Committee for Advanced Therapies

Martina Schüssler-Lenz, M.D.—Paul Ehrlich Institute

Importance of Early Active Engagement of Patients Throughout the Life Cycle of Drug Development

Mark W. Skinner, J.D.—Instiute for Policy Advancement, Ltd.

Clinical Path to Commercialization: Manufacturing Challenges

Kim Warren, Ph.D.—AvroBio